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FDA
Approves New Cordis
Carotid Stent
to Treat Clogged Neck Arteries Rapid Exchange Version of PRECISE® / ANGIOGUARD® System Approved; Company Announces Global Registry to track 10,000 Patients |
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| The advantage of the rapid exchange (RX) device is that it allows a single operator to perform the procedure. Prior to today's announcement, Cordis was the only company without an approved rapid exchange product. Other device manufacturers in this field are Abbott Vascular, Boston Scientific and eV3. Cordis Endovascular also announced that start of a worldwide 10,000 patient registry, named SAPPHIRE, after the clinical trial that led the the FDA approval. The registry will include up to 275 centers with a range of procedural volumes and will assess the 30-day rate of major adverse events (death, stroke or myocardial infarction) following the placement of the stent in high surgical risk patients with carotid artery disease. All procedures will also use the embolic distal protection device to prevent debris from traveling to the brain during the procedure. Results from a registry as large as this will help to confirm the safety of carotid stenting when compared to the open surgical alternative of carotid endarterectomy. Anil Chhabra, MD, Willis Knighton Medical Center in Shreveport, LA performed the first carotid case with the PRECISE® RX Nitinol Self-Expanding Stent and ANGIOGUARD® RX Emboli Capture Guidewire System in the United States. Dr. Chhabra said, "It's great to get the same devices on the rapid exchange delivery system. The ANGIOGUARD® RX Emboli Capture Guidewire System was very easy to advance through a very tight lesion and the auto tapering of the PRECISE® RX Nitinol Self-Expanding Stent was apparent in the excellent wall apposition across the different sized internal and common carotid arteries." Carotid arteries are the main blood vessels leading to the brain. The PRECISE® RX Nitinol Self-Expanding Stent and ANGIOGUARD® RX Emboli Capture Guidewire System are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA) -- a surgical treatment for removing arterial plaque from the carotid artery. The Cordis devices are the only carotid system backed by a large, randomized clinical trial -- the landmark SAPPHIRE study -- to support the potential benefits of carotid artery stenting (CAS) in patients who are ineligible, or considered high-risk, for carotid endarterectomy. " No other carotid artery stent and embolic protection system has been studied as extensively in as wide a range of high-risk patients as the PRECISE® RX Nitinol Self-Expanding Stent and ANGIOGUARD® RX Emboli Capture Guidewire System and we intend to continue building upon this important body of clinical evidence," said Dr. Dennis Donohoe, Vice President, Worldwide Clinical and Medical Affairs, Cordis Corporation. Carotid Artery DiseaseCarotid artery disease is the buildup of atherosclerotic plaque in the major neck vessels delivering blood to the brain, a major cause of stroke. CAS is a minimally invasive, non-surgical procedure intended to improve blood flow to the brain while helping prevent debris from entering cerebral circulation, and an important alternative for patients who are ineligible for CEA. Risk factors for carotid artery disease include advanced age, family history of stroke, plaque buildup in other areas of the body, high blood pressure, and diabetes. The American Heart Association estimates that 20 to 30 percent of strokes are associated with carotid artery disease, caused by particles of atherosclerotic plaque traveling into the vessels that supply the brain with oxygen and vital nutrients. Stroke affects an estimated 700,000 Americans each year, making it the nation's third leading cause of death, and a leading cause of serious, long-term disability. Cordis Endovascular Cordis Endovascular is a recognized leader in endovascular research and development and is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease. It constantly seeks solutions to the human anatomy's most challenging problems, such as carotid artery disease, superficial femoral artery disease, venous thrombotic disease, lower extremity disease and aortic aneurysm. Cordis Corporation Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. Source: Angioplasty.Org and Cordis Corporation |
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